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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-002304-14 | EudraCT Number |
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The purpose of this study is to generate safety, reactogenicity (assessment of any expected or unexpected side effect of the vaccine) and immunogenicity (ability to induce an immune response) data for the development of a candidate Clostridium difficile (C. difficile) vaccine that would protect against primary cases of Clostridium difficile infection (CDI) and CDI recurrence.
Clostridium difficile infection is a major cause of gastrointestinal illness with approximately 500,000 infections and the leading cause of gastroenteritis associated death with 29,000 deaths annually in the United States of America (USA). The emergence of extremely infectious varieties/types of C. difficile has contributed to increase the number and severity of CDI cases. In recent years, some countries (United Kingdom) have implemented hospital hygiene and other measures which resulted in significant reductions in the number of cases. The burden is, however, expected to remain significant until vaccination is available.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CDIFF Ag 18 - 45 Years Group | Experimental | Healthy male and female subjects, aged between and including 18 and 45 years old, who receive CDIFF antigen (Ag) vaccine administered intramuscularly in the deltoid, according to a 0, 1-month vaccination schedule. |
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| Placebo 18 - 45 Years Group | Placebo Comparator | Healthy male and female subjects, aged between and including 18 and 45 years old, who receive Placebo administered intramuscularly in the deltoid, according to a 0, 1-month vaccination schedule. |
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| CDIFF Ag 50 - 70 Years Group | Experimental | Healthy male and female subjects, aged between and including 50 and 70 years old, who receive CDIFF antigen (Ag) vaccine administered intramuscularly in the deltoid, according to a 0, 1-month vaccination schedule. A third dose of CDIFF Ag vaccine is to be administered to a subcohort of subjects aged 50-70 years, approximately 15 months after the administration of the second dose. |
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| CDIFF Ag + AS01B 50 - 70 Years Group | Experimental | Healthy male and female subjects, aged between and including 50 and 70 years old, who receive CDIFF Ag + AS01B adjuvant vaccine administered intramuscularly in the deltoid, according to a 0, 1-month vaccination schedule. A third dose of CDIFF Ag + AS01B adjuvant vaccine is to be administered to a subcohort of subjects aged 50-70 years, approximately 15 months after the administration of the second dose. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| C. difficile investigational vaccine based on the F2 antigen (GSK2904545A) | Biological | Subjects in CDIFF Ag 18 - 45 Years and CDIFF Ag 50 - 70 Years Groups will receive 2 or 3 doses (0.5 mL each) of CDIFF Ag vaccine. The vaccine will be administered intramuscularly in the deltoid, at a 0, 1-month dose interval. The third dose will be administered approximately 15 months after the second dose. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With Any and Grade 3 Solicited Local Symptoms, After Each Vaccine Dose | Assessed solicited local symptoms are pain at injection site, redness at injection site and swelling at injection site. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = significant pain at rest, pain that pre-vents normal every day activities. Grade 3 redness/swelling = redness/swelling with a maximum diameter greater (>) than 100 millimeters (mm). | During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after each vaccination |
| Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Assessed solicited general symptoms are fatigue, fever [defined as oral temperature equal to or higher than (>=) 38 degrees Celsius (°C)], gastrointestinal symptoms (nausea, vomiting, diarrhea, and/or abdominal pain), headache, myalgia, shivering and arthralgia. Any = occurrence of the symptom regardless of intensity grade and relationship to vaccination. Grade 3 symptom = symptom that prevents normal, everyday activities. Grade 3 fever = oral temperature higher (>) than 39.0°C. Related symptom = symptom assessed by the investigator as causally related to the study vaccination. Grade 3 related symptom = Grade 3 symptom assessed by the investigator as causally related to the study vaccination. | During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after each vaccination |
| Number of Subjects With Any, Grade 3, Related, Grade 3 Related and Medically Attended Unsolicited Adverse Events (AEs) | An unsolicited AE is any adverse event reported in addition to those solicited during the clinical study. Also, any "solicited" symptom with onset outside the specified period of follow-up for solicited symptoms is reported as an unsolicited adverse event. Potential unsolicited AEs may be medically attended (defined as symptoms or illnesses requiring hospitalization, or emergency room visit, or visit to/by a health care provider) or were of concern to the subjects. Any = occurrence of the symptom regardless of intensity grade and relationship to vaccination. Grade 3 symptom = symptom that prevents normal, everyday activities. Related symptom = symptom assessed by the investigator as causally related to the study vaccination. Grade 3 related symptom = Grade 3 symptom assessed by the investigator as causally related to the study vaccination. |
| Measure | Description | Time Frame |
|---|---|---|
| Serum Neutralizing Anti-Toxin A and Anti-Toxin B Antibody Titers, as Measured by Toxin Neutralization Assay (TNA) | Serum neutralizing anti-Toxin A and anti-Toxin B antibody titers are presented as Geometric Mean Titers (GMTs), as measured by TNA. | At Day 1, Day 31, Day 61, Day 180, Day 390, Day 491, Day 521 and Day 670 |
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Inclusion Criteria:
Subjects who, in the opinion of the Investigator, can and will comply with the requirements of the protocol.
Written or witnessed/thumb print informed consent obtained from the subject prior to performance of any study specific procedure.
For Step 1 only: A male or female between, and including, 18-45 years of age at the time of the first vaccination.
For Steps 2, 3, and 4: A male or female between, and including, 50-70 years of age at the time of the first vaccination.
Healthy subjects as established by medical history and clinical examination before entering into the study.
Subjects free of any uncontrolled chronic illnesses as established by medical history and clinical examination before entering into the study.
Female subjects of non-childbearing potential may be enrolled in the study.
Female subjects of childbearing potential may be enrolled in the study, if the subject:
Exclusion Criteria:
Health condition that, in the opinion of the Investigator, may interfere with optimal participation in the study or place the volunteer at increased risk of AEs. Study clinicians, in consultation with the Principal Investigator will use clinical judgment on a case by case basis to assess safety risks under this criterion. The Principal Investigator will consult with the Medical Monitor as appropriate.
Use of any investigational or nonregistered product other than the study vaccine(s) during the period starting 30 days before the first dose of study vaccine(s) (Day 29 to Day 1), or planned use during the study period.
Any medical condition that in the judgment of the Investigator would make IM injection unsafe and subjects under treatment with anticoagulant therapy.
Chronic administration of immunosuppressants or other immune modifying drugs during the period starting 3 months prior to the first vaccination. For corticosteroids, this will mean prednisone ≥ 5 milligrams per day (mg/day) (for adult subjects), or equivalent. Inhaled and topical steroids are allowed.
Administration of long acting immune modifying drugs at any time during the study period.
Administration of immunosuppressive therapy, including chemotherapeutic agents used to treat cancer or other conditions, and treatments associated with organ or bone marrow transplantation or autoimmune disease.
Administration of immunoglobulins and/or any blood products during the period starting 3 months before the first vaccination of study treatment or planned administration during the study period.
Planned administration/administration of a vaccine not foreseen by the study protocol in the period starting 6 weeks before the first vaccination and ending 6 weeks after the last vaccination, with the exception of inactivated influenza vaccine which can be administered up to 14 days before or from 30 days after the last study vaccination.
In case an emergency mass vaccination for an unforeseen public health threat (eg, a pandemic) is recommended and/or organized by public health authorities outside the routine immunization program, the time period described above can be reduced if, necessary for that vaccine, provided it is used according to the local governmental recommendations and that the Sponsor is notified accordingly.
Planned administration of GSK's Herpes Zoster vaccine marketed as Shingrix or an adjuvanted recombinant varicella zoster virus envelope gE subunit vaccine (HZ/su) within 180 days before the first dose and within 180 days after the last dose of the study vaccine.
Planned elective surgery during the study period.
Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational vaccine/product.
Body mass index < 19 kg/m^2 or ≥ 35 kg/m^2.
Clinically relevant physical examination abnormalities.
For subjects aged 18 - 45 years, Grade 2 or higher abnormal hematological, biochemical, and urinary parameters.
For subjects aged 50 - 70 years, Grade 3 or higher abnormal hematological, biochemical, and urinary parameters.
Documentation of current or prior episode of CDI.
Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
Recurrent history or uncontrolled neurological disorders or seizures.
Family history of congenital or hereditary immunodeficiency.
History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines.
Acute disease and/or fever at the time of enrollment.
Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic, or renal functional abnormality, as determined by physical examination or laboratory screening tests.
Pregnant or lactating female.
History of intestinal bleeding or history of diverticular intestinal bleeding.
Surgery for gastrointestinal malignancy in the period starting 3 months prior to the first vaccination.
History of chronic alcohol consumption and/or drug abuse as deemed by the Investigator to render the potential subject unable/unlikely to provide accurate safety reports.
Female planning to become pregnant or planning to discontinue contraceptive precautions.
Documented human immunodeficiency virus positive subject, known positivity for the surface antigen of the hepatitis B virus or known positive serologic test for the hepatitis C virus.
Involvement in the planning and/or conduct of the study.
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Ghent | 9000 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39447053 | Derived | Leroux-Roels I, Alhatemi A, Caubet M, De Boever F, de Wergifosse B, El Idrissi M, Ferreira GS, Jacobs B, Lambert A, Morel S, Servais C, Yarzabal JP. Safety and Immunogenicity of an Adjuvanted Clostridioides difficile Vaccine Candidate in Healthy Adults: A Randomized Placebo-Controlled Phase 1 Study. J Infect Dis. 2025 Mar 17;231(3):e511-e520. doi: 10.1093/infdis/jiae466. |
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IPD for this study will be made available via the Clinical Study Data Request site.
IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study
Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
Participants in this study were randomized in 5 groups on 2 age categories. After study interventions, as pre-assigned in protocol, the participants were followed up for safety, reactogenicity, and immunogenicity analysis until the end of the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | CDIFF Ag 18 - 45 Years Group | Healthy male and female subjects, aged between and including 18 and 45 years old, who receive CDIFF antigen (Ag) vaccine administered intramuscularly in the deltoid, according to a 0, 1-month vaccination schedule. |
| FG001 | Placebo 18 - 45 Years Group |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 6, 2021 | May 9, 2024 |
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A 4-step staggered design will be used to ensure maximum safety of the participating subjects:
Step 1: Vaccination of approximately 20 subjects aged 18-45 years. Step 2: Vaccination of approximately 20 subjects aged 50-70 years. Step 3: Vaccination of approximately 30 subjects aged 50-70 years. An iSRC will review all accumulating safety data after Dose 1 and 2 in Steps 1 to 3. If considered appropriate to proceed, the next step will start.
Step 4: Vaccination of approximately 70 subjects aged 50-70 years. An iSRC will review all accumulating safety data 3 weeks after the start of vaccination in Step 4 and then about every 3 weeks until all subjects have received Dose 1. In addition, the iSRC will review all safety data after Dose 2 and after that a subcohort of subjects will receive the third dose. If there are any safety concerns observed during SRT reviews post Dose 3, an ad hoc iSRC meeting will take place to review the unblinded safety data.
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This is a randomized, observer-blind and partial blind (only for third dose) study.
Given the different appearance of the C.difficile investigational vaccines and placebo, double blinding is not possible, and the study will be conducted in an observer-blind manner. In an observer-blind study, the subject, the Contract Research Organization personnel, and the study center and Sponsor personnel involved in the clinical evaluation of the subjects are blinded while other study personnel may be aware of the treatment assignment.
When all data up to Day 61 are available, a statistical analysis will be performed.This analysis may lead to the unblinding of some subjects.A statistician will be unblinded for the analysis.The study will be considered as partial blind from this point onwards.
The Investigator and the subjects will not have access to the treatment allocation up to Day 390. After Day 390, only the subjects will remain fully blinded, while the Investigator will be partially blinded.
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| Placebo 50 - 70 Years Group | Placebo Comparator | Healthy male and female subjects, aged between and including 50 and 70 years old, who receive Placebo administered intramuscularly in the deltoid, according to a 0, 1-month vaccination schedule. |
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| C. difficile investigational vaccine based on the F2 antigen (GSK2904545A) adjuvanted with AS01B | Biological | Subjects in CDIFF Ag + AS01B 50 - 70 Years Group will receive 2 or 3 doses (0.5 mL each) of CDIFF Ag + AS01B vaccine. The vaccine will be administered intramuscularly in the deltoid, at a 0, 1-month dose interval. The third dose will be administered approximately 15 months after the second dose. |
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| Placebo | Drug | Subjects will receive 2 doses (0.5 mL each) of Placebo, administered intramuscularly in the deltoid, at a 0, 1-month dose interval. |
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| During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after any vaccination |
| Number of Subjects With Serious Adverse Events (SAEs) | An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, represents a congenital anomaly/birth defect in the offspring of a study subject. | From Day 1 up to and including Day 390 (Epoch 001) |
| Number of Subjects With Potential Immune-mediated Diseases (pIMDs) | pIMDs are a subset of adverse events of specific interest (AESIs) that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune etiology. | During the whole study period (from Day 1 up to Day 390 [for subjects receiving 2 vaccine doses] and from Day 1 up to Day 670 [for subjects receiving 3 vaccine doses]) |
| Number of Subjects With Hematological, Biochemical, and Urinary Laboratory Abnormalities at Screening | Hematological (white blood cells, platelet count, hemoglobin level), biochemical (alanine aminotransferase, aspartate aminotransferase, creatinine, C-reactive protein and urate/uric acid) and urinary (protein, glucose and red blood cells) parameters are assessed. C-reactive protein is only assessed during the screening visit. Grades are based on the local laboratory normal ranges and derived from the FDA Toxicity Grading Scale for laboratory abnormalities. | At Screening (from Day -15 up to Day -1 [for subjects receiving 2 vaccine doses] and at Day 476 [for subjects receiving 3 vaccine doses]) |
| Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 8 | Hematological (white blood cells, platelet count, hemoglobin level), biochemical (alanine aminotransferase, aspartate aminotransferase, creatinine and urate/uric acid) parameters are assessed. Grades are based on the local laboratory normal ranges and derived from the FDA Toxicity Grading Scale for laboratory abnormalities. | At Day 8 |
| Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 31 | Hematological (white blood cells, platelet count, hemoglobin level), biochemical (alanine aminotransferase, aspartate aminotransferase, creatinine and urate/uric acid) parameters are assessed. Grades are based on the local laboratory normal ranges and derived from the FDA Toxicity Grading Scale for laboratory abnormalities. | At Day 31 |
| Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 38 | Hematological (white blood cells, platelet count, hemoglobin level), biochemical (alanine aminotransferase, aspartate aminotransferase, creatinine and urate/uric acid) parameters are assessed. Grades are based on the local laboratory normal ranges and derived from the FDA Toxicity Grading Scale for laboratory abnormalities. | At Day 38 |
| Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 180 | Hematological (white blood cells, platelet count, hemoglobin level), biochemical (alanine aminotransferase, aspartate aminotransferase, creatinine and urate/uric acid) parameters are assessed. Grades are based on the local laboratory normal ranges and derived from the FDA Toxicity Grading Scale for laboratory abnormalities. | At Day 180 |
| Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 390 | Hematological (white blood cells, platelet count, hemoglobin level), biochemical (alanine aminotransferase, aspartate aminotransferase, creatinine and urate/uric acid) parameters are assessed. Grades are based on the local laboratory normal ranges and derived from the FDA Toxicity Grading Scale for laboratory abnormalities. | At Day 390 |
| Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 476 | Hematological (white blood cells, platelet count, hemoglobin level), biochemical (alanine aminotransferase, aspartate aminotransferase, creatinine and urate/uric acid) parameters are assessed. Grades are based on the local laboratory normal ranges and derived from the FDA Toxicity Grading Scale for laboratory abnormalities. | At Day 476 |
| Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 491 | Hematological (white blood cells, platelet count, hemoglobin level), biochemical (alanine aminotransferase, aspartate aminotransferase, creatinine and urate/uric acid) parameters are assessed. Grades are based on the local laboratory normal ranges and derived from the FDA Toxicity Grading Scale for laboratory abnormalities. | At Day 491 |
| Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 670 | Hematological (white blood cells, platelet count, hemoglobin level), biochemical (alanine aminotransferase, aspartate aminotransferase, creatinine and urate/uric acid) parameters are assessed. Grades are based on the local laboratory normal ranges and derived from the FDA Toxicity Grading Scale for laboratory abnormalities. | At Day 670 |
Healthy male and female subjects, aged between and including 18 and 45 years old, who receive Placebo administered intramuscularly in the deltoid, according to a 0, 1-month vaccination schedule. |
| FG002 | CDIFF Ag 50 - 70 Years Group | Healthy male and female subjects, aged between and including 50 and 70 years old, who receive CDIFF antigen (Ag) vaccine administered intramuscularly in the deltoid, according to a 0, 1-month vaccination schedule. A third dose of CDIFF Ag vaccine was administered to a set of participants in this group, approximately 15 months after the administration of the second dose. |
| FG003 | CDIFF Ag + AS01B 50 - 70 Years Group | Healthy male and female subjects, aged between and including 50 and 70 years old, who receive CDIFF Ag + AS01B adjuvant vaccine administered intramuscularly in the deltoid, according to a 0, 1-month vaccination schedule. A third dose of CDIFF Ag + AS01B adjuvant vaccine was administered to a set of participants in this group, approximately 15 months after the administration of the second dose. |
| FG004 | Placebo 50 - 70 Years Group | Healthy male and female subjects, aged between and including 50 and 70 years old, who receive Placebo administered intramuscularly in the deltoid, according to a 0, 1-month vaccination schedule. |
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| ID | Title | Description |
|---|---|---|
| BG000 | CDIFF Ag 18 - 45 Years Group | Healthy male and female subjects, aged between and including 18 and 45 years old, who receive CDIFF antigen (Ag) vaccine administered intramuscularly in the deltoid, according to a 0, 1-month vaccination schedule. |
| BG001 | Placebo 18 - 45 Years Group | Healthy male and female subjects, aged between and including 18 and 45 years old, who receive Placebo administered intramuscularly in the deltoid, according to a 0, 1-month vaccination schedule. |
| BG002 | CDIFF Ag 50 - 70 Years Group | Healthy male and female subjects, aged between and including 50 and 70 years old, who receive CDIFF antigen (Ag) vaccine administered intramuscularly in the deltoid, according to a 0, 1-month vaccination schedule. A third dose of CDIFF Ag vaccine was administered to a set of participants in this group, approximately 15 months after the administration of the second dose. |
| BG003 | CDIFF Ag + AS01B 50 - 70 Years Group | Healthy male and female subjects, aged between and including 50 and 70 years old, who receive CDIFF Ag + AS01B adjuvant vaccine administered intramuscularly in the deltoid, according to a 0, 1-month vaccination schedule. A third dose of CDIFF Ag + AS01B adjuvant vaccine was administered to a set of participants in this group, approximately 15 months after the administration of the second dose. |
| BG004 | Placebo 50 - 70 Years Group | Healthy male and female subjects, aged between and including 50 and 70 years old, who receive Placebo administered intramuscularly in the deltoid, according to a 0, 1-month vaccination schedule. |
| BG005 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||
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| Primary | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, After Each Vaccine Dose | Assessed solicited local symptoms are pain at injection site, redness at injection site and swelling at injection site. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = significant pain at rest, pain that pre-vents normal every day activities. Grade 3 redness/swelling = redness/swelling with a maximum diameter greater (>) than 100 millimeters (mm). | The analysis is performed on the Solicited Safety Set, which included all subjects who received at least one dose of the study vaccine and for whom solicited safety data were available. | Posted | Count of Participants | Participants | During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after each vaccination |
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| Primary | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Assessed solicited general symptoms are fatigue, fever [defined as oral temperature equal to or higher than (>=) 38 degrees Celsius (°C)], gastrointestinal symptoms (nausea, vomiting, diarrhea, and/or abdominal pain), headache, myalgia, shivering and arthralgia. Any = occurrence of the symptom regardless of intensity grade and relationship to vaccination. Grade 3 symptom = symptom that prevents normal, everyday activities. Grade 3 fever = oral temperature higher (>) than 39.0°C. Related symptom = symptom assessed by the investigator as causally related to the study vaccination. Grade 3 related symptom = Grade 3 symptom assessed by the investigator as causally related to the study vaccination. | The analysis is performed on the Solicited Safety Set, which included all subjects who received at least one dose of the study vaccine and for whom solicited safety data were available. | Posted | Count of Participants | Participants | During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after each vaccination |
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| Primary | Number of Subjects With Any, Grade 3, Related, Grade 3 Related and Medically Attended Unsolicited Adverse Events (AEs) | An unsolicited AE is any adverse event reported in addition to those solicited during the clinical study. Also, any "solicited" symptom with onset outside the specified period of follow-up for solicited symptoms is reported as an unsolicited adverse event. Potential unsolicited AEs may be medically attended (defined as symptoms or illnesses requiring hospitalization, or emergency room visit, or visit to/by a health care provider) or were of concern to the subjects. Any = occurrence of the symptom regardless of intensity grade and relationship to vaccination. Grade 3 symptom = symptom that prevents normal, everyday activities. Related symptom = symptom assessed by the investigator as causally related to the study vaccination. Grade 3 related symptom = Grade 3 symptom assessed by the investigator as causally related to the study vaccination. | The analysis is performed on the Exposed Set, which included all subjects who received at least one dose of the study vaccine and for whom safety data were available. | Posted | Count of Participants | Participants | During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after any vaccination |
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| Primary | Number of Subjects With Serious Adverse Events (SAEs) | An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, represents a congenital anomaly/birth defect in the offspring of a study subject. | The analysis is performed on the Exposed Set, which included all subjects who received at least one dose of the study vaccine and for whom safety data were available. | Posted | Count of Participants | Participants | From Day 1 up to and including Day 390 (Epoch 001) |
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| Primary | Number of Subjects With Potential Immune-mediated Diseases (pIMDs) | pIMDs are a subset of adverse events of specific interest (AESIs) that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune etiology. | The analysis is performed on the Exposed Set, which included all subjects who received at least one dose of the study vaccine and for whom safety data were available. | Posted | Count of Participants | Participants | During the whole study period (from Day 1 up to Day 390 [for subjects receiving 2 vaccine doses] and from Day 1 up to Day 670 [for subjects receiving 3 vaccine doses]) |
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| Primary | Number of Subjects With Hematological, Biochemical, and Urinary Laboratory Abnormalities at Screening | Hematological (white blood cells, platelet count, hemoglobin level), biochemical (alanine aminotransferase, aspartate aminotransferase, creatinine, C-reactive protein and urate/uric acid) and urinary (protein, glucose and red blood cells) parameters are assessed. C-reactive protein is only assessed during the screening visit. Grades are based on the local laboratory normal ranges and derived from the FDA Toxicity Grading Scale for laboratory abnormalities. | The analysis is performed on the Enrolled Set, which included all subjects who signed the Informed Consent Form (ICF). | Posted | Count of Participants | Participants | At Screening (from Day -15 up to Day -1 [for subjects receiving 2 vaccine doses] and at Day 476 [for subjects receiving 3 vaccine doses]) |
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| Primary | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 8 | Hematological (white blood cells, platelet count, hemoglobin level), biochemical (alanine aminotransferase, aspartate aminotransferase, creatinine and urate/uric acid) parameters are assessed. Grades are based on the local laboratory normal ranges and derived from the FDA Toxicity Grading Scale for laboratory abnormalities. | The analysis is performed on the Enrolled Set, which included all subjects who signed the Informed Consent Form (ICF). | Posted | Count of Participants | Participants | At Day 8 |
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| Primary | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 31 | Hematological (white blood cells, platelet count, hemoglobin level), biochemical (alanine aminotransferase, aspartate aminotransferase, creatinine and urate/uric acid) parameters are assessed. Grades are based on the local laboratory normal ranges and derived from the FDA Toxicity Grading Scale for laboratory abnormalities. | The analysis is performed on the Enrolled Set, which included all subjects who signed the Informed Consent Form (ICF). | Posted | Count of Participants | Participants | At Day 31 |
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| Primary | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 38 | Hematological (white blood cells, platelet count, hemoglobin level), biochemical (alanine aminotransferase, aspartate aminotransferase, creatinine and urate/uric acid) parameters are assessed. Grades are based on the local laboratory normal ranges and derived from the FDA Toxicity Grading Scale for laboratory abnormalities. | The analysis is performed on the Enrolled Set, which included all subjects who signed the Informed Consent Form (ICF). | Posted | Count of Participants | Participants | At Day 38 |
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| Primary | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 180 | Hematological (white blood cells, platelet count, hemoglobin level), biochemical (alanine aminotransferase, aspartate aminotransferase, creatinine and urate/uric acid) parameters are assessed. Grades are based on the local laboratory normal ranges and derived from the FDA Toxicity Grading Scale for laboratory abnormalities. | The analysis is performed on the Enrolled Set, which included all subjects who signed the Informed Consent Form (ICF). | Posted | Count of Participants | Participants | At Day 180 |
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| Primary | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 390 | Hematological (white blood cells, platelet count, hemoglobin level), biochemical (alanine aminotransferase, aspartate aminotransferase, creatinine and urate/uric acid) parameters are assessed. Grades are based on the local laboratory normal ranges and derived from the FDA Toxicity Grading Scale for laboratory abnormalities. | The analysis is performed on the Enrolled Set, which included all subjects who signed the Informed Consent Form (ICF). | Posted | Count of Participants | Participants | At Day 390 |
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| Primary | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 476 | Hematological (white blood cells, platelet count, hemoglobin level), biochemical (alanine aminotransferase, aspartate aminotransferase, creatinine and urate/uric acid) parameters are assessed. Grades are based on the local laboratory normal ranges and derived from the FDA Toxicity Grading Scale for laboratory abnormalities. | The analysis is performed on the Enrolled Set, which included all subjects who signed the Informed Consent Form (ICF). | Posted | Count of Participants | Participants | At Day 476 |
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| Primary | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 491 | Hematological (white blood cells, platelet count, hemoglobin level), biochemical (alanine aminotransferase, aspartate aminotransferase, creatinine and urate/uric acid) parameters are assessed. Grades are based on the local laboratory normal ranges and derived from the FDA Toxicity Grading Scale for laboratory abnormalities. | The analysis is performed on the Enrolled Set, which included all subjects who signed the Informed Consent Form (ICF). | Posted | Count of Participants | Participants | At Day 491 |
| |||||||||||||||||||||||||||||||||||
| Primary | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 670 | Hematological (white blood cells, platelet count, hemoglobin level), biochemical (alanine aminotransferase, aspartate aminotransferase, creatinine and urate/uric acid) parameters are assessed. Grades are based on the local laboratory normal ranges and derived from the FDA Toxicity Grading Scale for laboratory abnormalities. | The analysis is performed on the Enrolled Set, which included all subjects who signed the Informed Consent Form (ICF). | Posted | Count of Participants | Participants | At Day 670 |
| |||||||||||||||||||||||||||||||||||
| Secondary | Serum Neutralizing Anti-Toxin A and Anti-Toxin B Antibody Titers, as Measured by Toxin Neutralization Assay (TNA) | Serum neutralizing anti-Toxin A and anti-Toxin B antibody titers are presented as Geometric Mean Titers (GMTs), as measured by TNA. | The analysis was performed on the Per-Protocol Set for analysis of immunogenicity, which included all subjects who received one dose of the study treatment to which they were randomized and have post-vaccination immunogenicity data available at the specified time point, minus the subjects with protocol deviations that lead to exclusion. | Posted | Geometric Mean | 95% Confidence Interval | Titer | At Day 1, Day 31, Day 61, Day 180, Day 390, Day 491, Day 521 and Day 670 |
|
Solicited local and systemic AEs were collected during the 7-day (Days 1-7) follow-up period after vaccination. Unsolicited AEs were collected during the 30-day (Day 1-30) follow-up period after vaccination. SAEs were collected from first vaccine dose (Day 1) up to study end (Day 670).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CDIFF Ag 18 - 45 Years Group | Healthy male and female subjects, aged between and including 18 and 45 years old, who receive CDIFF antigen (Ag) vaccine administered intramuscularly in the deltoid, according to a 0, 1-month vaccination schedule. | 0 | 10 | 0 | 10 | 8 | 10 |
| EG001 | Placebo 18 - 45 Years Group | Healthy male and female subjects, aged between and including 18 and 45 years old, who receive Placebo administered intramuscularly in the deltoid, according to a 0, 1-month vaccination schedule. | 0 | 10 | 1 | 10 | 6 | 10 |
| EG002 | CDIFF Ag + AS01B 50 - 70 Years Group | Healthy male and female subjects, aged between and including 50 and 70 years old, who receive CDIFF Ag + AS01B adjuvant vaccine administered intramuscularly in the deltoid, according to a 0, 1-month vaccination schedule. A third dose of CDIFF Ag + AS01B adjuvant vaccine was administered to a set of participants in this group, approximately 15 months after the administration of the second dose. | 0 | 45 | 3 | 45 | 45 | 45 |
| EG003 | CDIFF Ag 50 - 70 Years Group | Healthy male and female subjects, aged between and including 50 and 70 years old, who receive CDIFF antigen (Ag) vaccine administered intramuscularly in the deltoid, according to a 0, 1-month vaccination schedule. A third dose of CDIFF Ag vaccine was administered to a set of participants in this group, approximately 15 months after the administration of the second dose. | 0 | 45 | 3 | 45 | 32 | 45 |
| EG004 | Placebo 50 - 70 Years Group | Healthy male and female subjects, aged between and including 50 and 70 years old, who receive Placebo administered intramuscularly in the deltoid, according to a 0, 1-month vaccination schedule. | 0 | 30 | 0 | 30 | 23 | 30 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Erysipelas | Infections and infestations | MedDRA v22.0 | Systematic Assessment |
| |
| Foot fracture | Injury, poisoning and procedural complications | MedDRA v22.0 | Systematic Assessment |
| |
| Wrist fracture | Injury, poisoning and procedural complications | MedDRA v22.0 | Systematic Assessment |
| |
| Rotator cuff syndrome | Musculoskeletal and connective tissue disorders | MedDRA v22.0 | Systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v22.0 | Systematic Assessment |
| |
| Malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v22.0 | Systematic Assessment |
| |
| Peripheral arterial occlusive disease | Vascular disorders | MedDRA v22.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ear pain | Ear and labyrinth disorders | MedDRA v22.0 | Systematic Assessment |
| |
| Swelling of eyelid | Eye disorders | MedDRA v22.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA v22.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA v22.0 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA v22.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA v22.0 | Systematic Assessment |
| |
| Gastrointestinal disorder | Gastrointestinal disorders | MedDRA v22.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA v22.0 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA v22.0 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA v22.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA v22.0 | Systematic Assessment |
| |
| Injection site erythema | General disorders | MedDRA v22.0 | Systematic Assessment |
| |
| Injection site pain | General disorders | MedDRA v22.0 | Systematic Assessment |
| |
| Injection site pruritus | General disorders | MedDRA v22.0 | Systematic Assessment |
| |
| Injection site swelling | General disorders | MedDRA v22.0 | Systematic Assessment |
| |
| Injection site warmth | General disorders | MedDRA v22.0 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA v22.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA v22.0 | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA v22.0 | Systematic Assessment |
| |
| Folliculitis | Infections and infestations | MedDRA v22.0 | Systematic Assessment |
| |
| Gastrointestinal infection | Infections and infestations | MedDRA v22.0 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA v22.0 | Systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA v22.0 | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA v22.0 | Systematic Assessment |
| |
| Skin infection | Infections and infestations | MedDRA v22.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA v22.0 | Systematic Assessment |
| |
| Arthropod sting | Injury, poisoning and procedural complications | MedDRA v22.0 | Systematic Assessment |
| |
| Ligament rupture | Injury, poisoning and procedural complications | MedDRA v22.0 | Systematic Assessment |
| |
| Limb injury | Injury, poisoning and procedural complications | MedDRA v22.0 | Systematic Assessment |
| |
| Meniscus injury | Injury, poisoning and procedural complications | MedDRA v22.0 | Systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA v22.0 | Systematic Assessment |
| |
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA v22.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA v22.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA v22.0 | Systematic Assessment |
| |
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA v22.0 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA v22.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA v22.0 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA v22.0 | Systematic Assessment |
| |
| Periarthritis | Musculoskeletal and connective tissue disorders | MedDRA v22.0 | Systematic Assessment |
| |
| Tendon disorder | Musculoskeletal and connective tissue disorders | MedDRA v22.0 | Systematic Assessment |
| |
| Melanocytic naevus | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v22.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA v22.0 | Systematic Assessment |
| |
| Dizziness exertional | Nervous system disorders | MedDRA v22.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA v22.0 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA v22.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA v22.0 | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA v22.0 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA v22.0 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA v22.0 | Systematic Assessment |
| |
| Papule | Skin and subcutaneous tissue disorders | MedDRA v22.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA v22.0 | Systematic Assessment |
| |
| Rash erythematous | Skin and subcutaneous tissue disorders | MedDRA v22.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA v22.0 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA v22.0 | Systematic Assessment |
|
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single site data not precede the primary publication of the entire clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 | GSKClinicalSupportHD@gsk.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 1, 2021 | May 9, 2024 | SAP_001.pdf |
| ID | Term |
|---|---|
| D003015 | Clostridium Infections |
| ID | Term |
|---|---|
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
Not provided
Not provided
| Male |
|
|
| Grade 3 Erythema, after Dose 1 |
|
|
| Any Pain, after Dose 1 |
|
|
| Grade 3 Pain, after Dose 1 |
|
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| Any Swelling, after Dose 1 |
|
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| Grade 3 Swelling, after Dose 1 |
|
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| Any Erythema, after Dose 2 |
|
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| Grade 3 Erythema, after Dose 2 |
|
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| Any Pain, after Dose 2 |
|
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| Grade 3 Pain, after Dose 2 |
|
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| Any Swelling, after Dose 2 |
|
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| Grade 3 Swelling, after Dose 2 |
|
|
Healthy male and female subjects, aged between and including 18 and 45 years old, who receive Placebo administered intramuscularly in the deltoid, according to a 0, 1-month vaccination schedule.
| OG002 | CDIFF Ag 50 - 70 Years Group | Healthy male and female subjects, aged between and including 50 and 70 years old, who receive CDIFF antigen (Ag) vaccine administered intramuscularly in the deltoid, according to a 0, 1-month vaccination schedule. A third dose of CDIFF Ag vaccine was administered to a set of participants in this group, approximately 15 months after the administration of the second dose. |
| OG003 | CDIFF Ag + AS01B 50 - 70 Years Group | Healthy male and female subjects, aged between and including 50 and 70 years old, who receive CDIFF Ag + AS01B adjuvant vaccine administered intramuscularly in the deltoid, according to a 0, 1-month vaccination schedule. A third dose of CDIFF Ag + AS01B adjuvant vaccine was administered to a set of participants in this group, approximately 15 months after the administration of the second dose. |
| OG004 | Placebo 50 - 70 Years Group | Healthy male and female subjects, aged between and including 50 and 70 years old, who receive Placebo administered intramuscularly in the deltoid, according to a 0, 1-month vaccination schedule. |
|
|
| Placebo 18 - 45 Years Group |
Healthy male and female subjects, aged between and including 18 and 45 years old, who receive Placebo administered intramuscularly in the deltoid, according to a 0, 1-month vaccination schedule. |
| OG002 | CDIFF Ag 50 - 70 Years Group | Healthy male and female subjects, aged between and including 50 and 70 years old, who receive CDIFF antigen (Ag) vaccine administered intramuscularly in the deltoid, according to a 0, 1-month vaccination schedule. A third dose of CDIFF Ag vaccine was administered to a set of participants in this group, approximately 15 months after the administration of the second dose. |
| OG003 | CDIFF Ag + AS01B 50 - 70 Years Group | Healthy male and female subjects, aged between and including 50 and 70 years old, who receive CDIFF Ag + AS01B adjuvant vaccine administered intramuscularly in the deltoid, according to a 0, 1-month vaccination schedule. A third dose of CDIFF Ag + AS01B adjuvant vaccine was administered to a set of participants in this group, approximately 15 months after the administration of the second dose. |
| OG004 | Placebo 50 - 70 Years Group | Healthy male and female subjects, aged between and including 50 and 70 years old, who receive Placebo administered intramuscularly in the deltoid, according to a 0, 1-month vaccination schedule. |
|
|
| OG003 | CDIFF Ag + AS01B 50 - 70 Years Group | Healthy male and female subjects, aged between and including 50 and 70 years old, who receive CDIFF Ag + AS01B adjuvant vaccine administered intramuscularly in the deltoid, according to a 0, 1-month vaccination schedule. A third dose of CDIFF Ag + AS01B adjuvant vaccine was administered to a set of participants in this group, approximately 15 months after the administration of the second dose. |
| OG004 | Placebo 50 - 70 Years Group | Healthy male and female subjects, aged between and including 50 and 70 years old, who receive Placebo administered intramuscularly in the deltoid, according to a 0, 1-month vaccination schedule. |
|
|
Healthy male and female subjects, aged between and including 50 and 70 years old, who receive CDIFF antigen (Ag) vaccine administered intramuscularly in the deltoid, according to a 0, 1-month vaccination schedule. A third dose of CDIFF Ag vaccine was administered to a set of participants in this group, approximately 15 months after the administration of the second dose.
| OG003 | CDIFF Ag + AS01B 50 - 70 Years Group | Healthy male and female subjects, aged between and including 50 and 70 years old, who receive CDIFF Ag + AS01B adjuvant vaccine administered intramuscularly in the deltoid, according to a 0, 1-month vaccination schedule. A third dose of CDIFF Ag + AS01B adjuvant vaccine was administered to a set of participants in this group, approximately 15 months after the administration of the second dose. |
| OG004 | Placebo 50 - 70 Years Group | Healthy male and female subjects, aged between and including 50 and 70 years old, who receive Placebo administered intramuscularly in the deltoid, according to a 0, 1-month vaccination schedule. |
|
|
| OG002 |
| CDIFF Ag 50 - 70 Years Group |
Healthy male and female subjects, aged between and including 50 and 70 years old, who receive CDIFF antigen (Ag) vaccine administered intramuscularly in the deltoid, according to a 0, 1-month vaccination schedule. A third dose of CDIFF Ag vaccine was administered to a set of participants in this group, approximately 15 months after the administration of the second dose. |
| OG003 | CDIFF Ag + AS01B 50 - 70 Years Group | Healthy male and female subjects, aged between and including 50 and 70 years old, who receive CDIFF Ag + AS01B adjuvant vaccine administered intramuscularly in the deltoid, according to a 0, 1-month vaccination schedule. A third dose of CDIFF Ag + AS01B adjuvant vaccine was administered to a set of participants in this group, approximately 15 months after the administration of the second dose. |
| OG004 | Placebo 50 - 70 Years Group | Healthy male and female subjects, aged between and including 50 and 70 years old, who receive Placebo administered intramuscularly in the deltoid, according to a 0, 1-month vaccination schedule. |
|
|
| OG003 | CDIFF Ag + AS01B 50 - 70 Years Group | Healthy male and female subjects, aged between and including 50 and 70 years old, who receive CDIFF Ag + AS01B adjuvant vaccine administered intramuscularly in the deltoid, according to a 0, 1-month vaccination schedule. A third dose of CDIFF Ag + AS01B adjuvant vaccine was administered to a set of participants in this group, approximately 15 months after the administration of the second dose. |
| OG004 | Placebo 50 - 70 Years Group | Healthy male and female subjects, aged between and including 50 and 70 years old, who receive Placebo administered intramuscularly in the deltoid, according to a 0, 1-month vaccination schedule. |
|
|
| OG003 | CDIFF Ag + AS01B 50 - 70 Years Group | Healthy male and female subjects, aged between and including 50 and 70 years old, who receive CDIFF Ag + AS01B adjuvant vaccine administered intramuscularly in the deltoid, according to a 0, 1-month vaccination schedule. A third dose of CDIFF Ag + AS01B adjuvant vaccine was administered to a set of participants in this group, approximately 15 months after the administration of the second dose. |
| OG004 | Placebo 50 - 70 Years Group | Healthy male and female subjects, aged between and including 50 and 70 years old, who receive Placebo administered intramuscularly in the deltoid, according to a 0, 1-month vaccination schedule. |
|
|
| OG003 | CDIFF Ag + AS01B 50 - 70 Years Group | Healthy male and female subjects, aged between and including 50 and 70 years old, who receive CDIFF Ag + AS01B adjuvant vaccine administered intramuscularly in the deltoid, according to a 0, 1-month vaccination schedule. A third dose of CDIFF Ag + AS01B adjuvant vaccine was administered to a set of participants in this group, approximately 15 months after the administration of the second dose. |
| OG004 | Placebo 50 - 70 Years Group | Healthy male and female subjects, aged between and including 50 and 70 years old, who receive Placebo administered intramuscularly in the deltoid, according to a 0, 1-month vaccination schedule. |
|
|
| OG003 | CDIFF Ag + AS01B 50 - 70 Years Group | Healthy male and female subjects, aged between and including 50 and 70 years old, who receive CDIFF Ag + AS01B adjuvant vaccine administered intramuscularly in the deltoid, according to a 0, 1-month vaccination schedule. A third dose of CDIFF Ag + AS01B adjuvant vaccine was administered to a set of participants in this group, approximately 15 months after the administration of the second dose. |
| OG004 | Placebo 50 - 70 Years Group | Healthy male and female subjects, aged between and including 50 and 70 years old, who receive Placebo administered intramuscularly in the deltoid, according to a 0, 1-month vaccination schedule. |
|
|
| OG003 | CDIFF Ag + AS01B 50 - 70 Years Group | Healthy male and female subjects, aged between and including 50 and 70 years old, who receive CDIFF Ag + AS01B adjuvant vaccine administered intramuscularly in the deltoid, according to a 0, 1-month vaccination schedule. A third dose of CDIFF Ag + AS01B adjuvant vaccine was administered to a set of participants in this group, approximately 15 months after the administration of the second dose. |
| OG004 | Placebo 50 - 70 Years Group | Healthy male and female subjects, aged between and including 50 and 70 years old, who receive Placebo administered intramuscularly in the deltoid, according to a 0, 1-month vaccination schedule. |
|
|
| OG003 | CDIFF Ag + AS01B 50 - 70 Years Group | Healthy male and female subjects, aged between and including 50 and 70 years old, who receive CDIFF Ag + AS01B adjuvant vaccine administered intramuscularly in the deltoid, according to a 0, 1-month vaccination schedule. A third dose of CDIFF Ag + AS01B adjuvant vaccine was administered to a set of participants in this group, approximately 15 months after the administration of the second dose. |
| OG004 | Placebo 50 - 70 Years Group | Healthy male and female subjects, aged between and including 50 and 70 years old, who receive Placebo administered intramuscularly in the deltoid, according to a 0, 1-month vaccination schedule. |
|
|
| OG003 | CDIFF Ag + AS01B 50 - 70 Years Group | Healthy male and female subjects, aged between and including 50 and 70 years old, who receive CDIFF Ag + AS01B adjuvant vaccine administered intramuscularly in the deltoid, according to a 0, 1-month vaccination schedule. A third dose of CDIFF Ag + AS01B adjuvant vaccine was administered to a set of participants in this group, approximately 15 months after the administration of the second dose. |
| OG004 | Placebo 50 - 70 Years Group | Healthy male and female subjects, aged between and including 50 and 70 years old, who receive Placebo administered intramuscularly in the deltoid, according to a 0, 1-month vaccination schedule. |
|
|
| OG003 | CDIFF Ag + AS01B 50 - 70 Years Group | Healthy male and female subjects, aged between and including 50 and 70 years old, who receive CDIFF Ag + AS01B adjuvant vaccine administered intramuscularly in the deltoid, according to a 0, 1-month vaccination schedule. A third dose of CDIFF Ag + AS01B adjuvant vaccine was administered to a set of participants in this group, approximately 15 months after the administration of the second dose. |
| OG004 | Placebo 50 - 70 Years Group | Healthy male and female subjects, aged between and including 50 and 70 years old, who receive Placebo administered intramuscularly in the deltoid, according to a 0, 1-month vaccination schedule. |
|
|
Healthy male and female subjects, aged between and including 50 and 70 years old, who receive CDIFF antigen (Ag) vaccine administered intramuscularly in the deltoid, according to a 0, 1-month vaccination schedule. A third dose of CDIFF Ag vaccine was administered to a set of participants in this group, approximately 15 months after the administration of the second dose. |
| OG003 | CDIFF Ag + AS01B 50 - 70 Years Group | Healthy male and female subjects, aged between and including 50 and 70 years old, who receive CDIFF Ag + AS01B adjuvant vaccine administered intramuscularly in the deltoid, according to a 0, 1-month vaccination schedule. A third dose of CDIFF Ag + AS01B adjuvant vaccine was administered to a set of participants in this group, approximately 15 months after the administration of the second dose. |
| OG004 | Placebo 50 - 70 Years Group | Healthy male and female subjects, aged between and including 50 and 70 years old, who receive Placebo administered intramuscularly in the deltoid, according to a 0, 1-month vaccination schedule. |
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